Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy

University of Arkansas

Status and phase

Withdrawn

Early Phase 1

Conditions

Squamous Cell Carcinoma of the Head and Neck

Treatments

Drug: 18F-MISO

Study type

Interventional

Funder types

Other

Identifiers

NCT01967927

138725 (Other Grant/Funding Number)

Details and patient eligibility

About

To estimate the mean and standard deviation (SD) of the post-treatment decreases in the interstitial fluid pressure and hypoxia-specific PET-scan signal from GRID-treated tumors in patients with locally advanced squamous-cell carcinoma of the head and neck.

The possible effects of GRID radiotherapy on tumor oxygenation levels and interstitial fluid pressure within the tumors will be measured by assessing the trend and statistical significance of the difference in values for each condition obtained prior to and just after GRID exposure in each subject enrolled in the study. We expect that there may be a trend for increases in tumor oxygenation and decreases in interstitial fluid pressure which would indicate that more accurately timed additional chemotherapy and radiation therapy would improve overall patient outcomes.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 - 80 years of age
Karnofsky performance status greater than 70 or ECOG ≥ 2
Cytological or histological documentation of squamous cell carcinoma of the head and neck, including the tongue, with a minimum tumor size of 6cm in any dimension.
History of adequate hepatic function (endoscopic or percutaneous drainage as needed):

a. AST (SGOT) / ALT (SGPT) ≤ 5X institutional ULN
Chemotherapy naive
History of adequate renal and bone marrow function:
1. Leukocytes ≥ 3000/uL
2. ANC ≥ 1500/uL
3. Platelets ≥ 100000/UI
4. Serum Creatinine ≤ 2.0 mg/dL

Exclusion criteria

Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
Subjects with active infections such as pneumonia, or wound infections that would preclude study procedures
Subjects with known presence of central nervous system or brain metastases
Subjects with prior radiotherapy to the head and neck region
Subjects will be excluded if deemed unable to comply with study procedures